A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5025 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab (Humira) Treatment

Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbvie sponsored investigational Crohn's disease (CD) trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
* Subjects who were participants in AbbVie sponsored investigational Crohn's CD trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
* Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
* Subjects willing to consent to data being collected and provided to AbbVie.
* Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.